VetGraft’s core value is to drive the development of tissue bank products for veterinary patients that are innovative, effective, safe and clinically successful.

VetGraft LLC is a veterinary tissue bank that manufactures an injectable biologic tissue particulate
(PulpCyte™) for equine musculoskeletal injuries. The product is derived from foals that have passed away during the birthing process from dystocia or injury. All recovered tissue is handled according to human tissue bank standards (Good Tissue Practices, GTP) as set forth by the American Association of Tissue Banking (AATB) guidelines to ensure the ethical procurement and use of the tissues. VetGraft adheres to Good Manufacturing Processes (GMP) as per ISO 9001:2015.

This tissue is processed mechanically without the aid of digestion creating a 361 minimally manipulated cell and connective tissue particulate. It would be considered homologous use for ligament, tendon, bursa and laminitis cases. According to VetGraft’s quality management system, a series of product validation tests are performed on each recovery (DIN – Donor Identification Number) to ensure the reproducibility and quality of the product. The tissue is sent out for Serology testing to ensure the absence of any viral contamination and microbial assays are performed to ensure no bacterial contamination. Additionally, flow cytometry is used to confirm the viability count and that the percentage of mesenchymal and hematopoietic markers meet product requirements. Once passing quarantine and validation, the tissue is moved to long term cryopreservation liquid nitrogen storage.

When an order is placed, the tissue particulate is thawed and an injection is made to the desired concentration specific to injury and veterinarian preferences. A product insert and tracking form with return envelope is sent with each injection along with two unique injection labels. One label is placed in the patients’ chart and the other on the tissue tracking form that is returned to VetGraft for our tissue banking records. We track all reported adverse events as per AATB requirements.

Product — The standard PulpCyte injection contains 10 million minimally manipulated stem cells along with extracellular matrix proteins in 2cc of solution. Its’ sterility is rechecked by agar plating when we ship the product overnight AM delivery and confirmed the next morning before it arrives. This is unique to our product as all other stem cell products are shipped frozen and not checked for sterility. Different solutions and concentrations can be order for specific indications (10million in 20cc for perfusion). The extra cellular matrix includes native growth factors & proteins similar to PRP and IRAP but containing a much higher concentration (400X). Additionally, due to intact surrounding extracellular matrix, PulpCyte has the unique ability to survive anaerobic conditions and therefore, has a 10-day shelf life if kept refrigerated as determined by propidium iodine & confocal microscopy. Each PulpCyte vial contains the same number of cells and concentration of proteins, and therefore, there is no product variability.

Science — The PulpCyte™ product contains unduplicated cells that have not been manipulated or subjected to digestive processes required with cultured products (that manipulate stem cells). The very unique ability of our minimally manipulated product to maintain 10 Day+ viability after thawing is most likely due to the stem cells being surrounded by their native ECM (Extracellular Matrix) contaiming multiple proteins with anti-inflammatory properties as well as all the collagen precursors. In addition, the cells are received the next day by veterinarians and is able to be used within 10 days if refrigerated to allow scheduling variation. There is no donor morbidity when using PulpCyte and to date no adverse reactions. Toxicity and tumorgenicity studies have demonstrated safety and lack of tumor formation in standard rat and Nude Mice testing, respectively. Co-culture analysis of peripheral mononuclear cells from horses receiving donor cells have shown no upregulation of graft rejection markers or immune response from their baseline numbers.

Clinical Results — Over 158 veterinarians have successfully treated equine conditions including OA, tendon and ligament injuries as well as tendonitis, navicular bursitis and Laminitis. VetGraft has tracked over 3000+ treatment doses over the past 4 years. Recently we published a randomized, controlled and blinded 40 horse clinical trial at OSU of our PulpCyte product in horses with OA and ligament injuries in Frontiers in Veterinary Science. Additionally, we have non-published data from a 40 - horse field trial at Cleveland Equine Clinic in Ohio where Dr. Ron Genovese VMD found a 70% + return to previous function in race and competition horses after single treatment with PulpCyte. As all the horses are now 3+ years post treatment, we are currently re-evaluating as many of these animals as we can locate for publication. Early results of these long term follow up in the tendon injury groups show no adverse effects and many sustained successes even with the protocol's single injection. But, some tendon injuries were subsequently retreated, or other tendons injected for different injuries, as is common in these horses.

OUR BOARD

Ray C. Wasielewski MS, MD

Dr. Wasielewski is the Chairman, Management Committee of JointVue, LLC a company focusing on commercialization of ultrasound and other non-invasive diagnostic modalities. He is a Board Certified Orthopedic Hip & Knee surgeon; member of The Knee Society and holds multiple patents on orthopedic implants and stem cell biologics. He holds a BS & MS in Materials Engineering from Virginia Tech.

Kristie Krug

Vice President and CTO of VetGraft, LLC
President of Cytolutions, LLC

Ms. Krug also serves as President of Cytolutions, LLC, a biotech services company focusing on rare cell detection and characterization using fluorescence and magnetic techniques. She is a Microbiologist with extensive stem cell science background and also in Chemical Engineering for 12 years. She holds several patents on magnetic cell separation from reagents to instrumentation.

Tom Washbush

Principal, Washbush Law
Chair of the Business, Tax and Estates group, and the Cybersecurity group at Brickler & Eckler

Mr. Washbush has over 25 years of experience as a corporate and finance partner closing hundreds of deals and has represented or worked with over 60 venture and private equity firms and has served as fund formation counsel for numerous firms. He has also served as a trusted advisor to business owners and CEOs where he brings not only his legal expertise, but also his business experience. Recently, Mr. Washbush served as Chair of the Business Practice Group and Cyber security Group of Bricker & Eckler, LLP. He is the former Partner in Charge and Executive Committee Member of Benesch.

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PRIVACY POLICY

This Website is operated by StemLutions, LLC. (the “Company”). By accessing, browsing, visiting or in any way using this Website (“Site” or “Website”), you acknowledge having read and understood the Privacy Policy (“Policy”), and you agree that you are subject to all terms and conditions contained herein. This Policy is a binding agreement between the Company and you. If you do not agree to any of these terms, you may not use the Website.
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This policy explains what information we collect about you when you visit our Website and how we handle such information. The information we collect and how we use such information depends upon what you do when visiting our Site.

To serve your privacy needs and to adapt to changing legal and industry standards, the Company reserves the right, at its discretion, to update or revise the Agreements. You are encouraged to review the Agreements, and the other policies, terms and conditions, and notices posted on this Site from time to time. Your continued use of the Site following any posted revisions constitutes your acceptance of such changes. Additionally, by purchasing products, or in submitting information in connection with the Site’s online forms or search fields, you reiterate your agreement to the modified terms. You also understand and agree that if you use the Site after the date on which these Terms of Use has been amended, the Company will treat your use as an acceptance of the updated Terms of Use or additional terms. Nothing in these Terms of Use shall be deemed to confer any third-party rights or benefits.

Information Collected from All Visitors

For all visitors, we collect and store non-personally-identifiable information including the name of the domain from which you access the Internet (for example, aol.com, if you are connecting from an America Online account); the date and time you access our Site; and the Internet address of the Website from which you linked directly to our Site. We use the information we collect to measure the number of visitors to the different sections of our Site, to help us make our Site more useful to visitors, to help diagnose problems, to help identify you, and to generally administer the Website.

Information Collected from Certain Visitors

In addition to the general information collected from all visitors to the Website, in order to access some of the features of the Website, you will be required to disclose additional information.

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We may share information with third party suppliers who agree to protect its confidentiality. This information may include the aggregate data collected regarding the visitors to the Website and certain information that may have been provided to the Company by you. The Company may also choose to share aggregate usage information for marketing purposes; provided, however, that this will generally not include the sharing of your personal information.

From time to time, the Company may also enter into a special relationship with another company that is not owned by the Company to provide additional features on the Site. These special relationships may include “powered by” partners, business partners, sponsors, and co-branded Sites (referred to here as “Co-Branded Pages”). These might include, for example, pages that share our name and that of another entity. You should look for a specific privacy statement on any such Co-Branded Page. Any personal information that you provide when signing up at one of those Co-Branded Pages may be shared with our third-party partner. You should also check our partner’s Website for information regarding its privacy policies.

We employ other companies and individuals to perform functions on our behalf, including technical support services. To perform those functions, it may be necessary for them to obtain access to the Company’s databases and servers, which may contain personally identifying information about users. They are not permitted to use such access or information for any purpose other than that for which they are retained, but the Company cannot guarantee that such third parties will not abuse their access privileges.

We will also disclose any information we possess in response to subpoenas, court orders, or legal requirements, and such information might be used by the receiving party to determine your identity, your web usage and online behavior or other things about you. We generally do not inform users of such requests for information, although we might try to do so in some cases.

If this Site is sold to, or merges with, another company not owned by the Company, you should expect that some or all of the information collected from this Website may be transferred to the buyer or surviving company. If so, the Company will seek to obligate the acquiring company to use any personal information transferred by this Site in a manner consistent with this Policy, but cannot guarantee that it will be able to impose that requirement or that the acquiring company will comply.

Except as otherwise described in this Policy, the Company will not disclose personal information to any third party unless we believe that disclosure is necessary: (1) to conform to legal requirements or to respond to a subpoena, search warrant or other legal process received by the Company, whether or not a response is required by applicable law; (2) to enforce the Company Terms of Services Agreement or to protect our rights; or (3) to protect the safety of the members of the public and users of the service.

If at any time you would like your personal information deleted from the Website or the Company’s records, please email us with your request and we will delete this information.

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Linked Sites

This Site may link you to other Sites on the Internet (“Linked Sites”). The Linked Sites are not under the Company’s control, and the Company is not responsible for the content of any Linked Sites, including without limitation the accuracy, copyright compliance, legality, or decency of the Linked Sites or any links contained therein. These links are provided for your convenience, and do not imply endorsement of the Linked Sites by the Company or any association with its operators. If you choose to send personally-identifying information to Linked Sites, you do so at your own risk. We do not control the collection or use of this information, and we make no representations about the privacy policies or practices of other Sites. Accordingly, we encourage you to be aware when you leave the Website and to read the terms and conditions and privacy policy of each other Website that you visit.

User Content

Feedback and other comments and statements that you choose to submit to the Company by any means – whether by email, telephone, letter or any other means – shall be considered nonconfidential and the Company is free to use such information on an unrestricted basis. You are strongly urged not to post any personal information that you expect to be kept private.

General

The Site is operated from a location in the State of Ohio, United States of America. We make no representation that materials found at our Sites are appropriate or available for use in other locations. If you access our Site from other locations, you are responsible for compliance with local laws.